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Three Keys to Global Harmonization in Quality: Learning to Share

  
  
  

Global Harmonization of Enterprise Compliance Systems

Growing up, I never was one to want to share my toys.  I wasn’t one to throw a temper tantrum and take my toys home, but I never really liked the whole concept of people touching my stuff.  Thinking back on it, it all boiled down to the fact that I kept my toys in a certain working order, and I didn’t want little Jimmy MacMillan going and getting his scummy hands all over it.

When I hear people talk about the challenges behind a global harmonization initiative, I can help but think of a group of kids not wanting to share the toys.  Each site within the organization, operating under their own Quality Management System, happy to have their specific processes just the way they like them.  Then someone comes along and says, “We’re going to standardize on a single platform”.  It’s akin to mom saying, “We’re going to pool all the neighborhood kids toys together into one room, and everyone is going to share (even dirty Jimmy Macmillan).   There are inherent challenges to harmonizing a solution, especially Quality Management.  However, with the right tools, harmonization can actually enable a single standardized environment, while at the same time sustaining each site’s unique business processes.  Below are a few key considerations when harmonizing your Quality Management System:

1. Ask, “How can we all be Common, but Keep our Processes and Data Unique?”  Perhaps the biggest challenge leading into a harmonization/standardization initiative is convincing the site-level managers to adopt the system.  Many times, each site will want to keep their specific processes and fear that a harmonization may compromise their unique way of doing business.  When harmonizing a system, traditional methods would warrant that all site need to adopt the corporate standard, and fit into the “mold” that is set in front of them.  With today’s advances in technology, it is now possible to be “common” on a corporate level, while maintaining the unique processes associated with each site’s unique processes.  The key lies in the technology.

2.  The Technology Platform needs to Support Harmonization.  Technology is constantly evolving, and each new advancement, brings business systems closer together.  For harmonization projects to be successful, the software solution needs to be flexible enough to adapt to the concept of having multiple processes operating on a corporate standard.  Leading edge Quality Management Software Solutions are able to have site-level processes layered on top of a corporate backbone – each site is able to retain the specific data points that are pertinent to them, while keeping in line with the standardized, corporate process.  This allows the enterprise to be common and unique at the same time.

3.  Get a Strong Project Team to Work Out the Details.  I can talk about the technology all day long, but the reality is, the technology is only as effective as the team that is implementing it.  Harmonization, by definition, is a group operating in the same direction – the team must be able to work together to get the business requirements to building a standardized solution.  This involves looking at the stakeholders of the system (at the corporate level and the site level), the inputs required across the enterprise, the processes that govern the system, the desired outputs that the team expects to see, and how the results be measured and managed.  This methodology will spit out a set of requirements, which if done properly, will create a framework for a harmonized system.  But each team member must contribute and commit to the cause.  When starting the journey towards harmonization, there will be bumps along the way.  Not all processes will fit together, and there will need to be compromises.  It is important that the project team stay focused on the ultimate goal - the stronger the team, the better the end result will be. 

A strong team builds innovation, the technology drives the innovation.  The combination of these two elements will then answer the question, “how can we all be common, but keep our processes and data unique?”

 Then, and only then – will we share our toys.

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